Cleared Traditional

K062341 - MALE REMEEX SYSTEM

K062341 is an FDA 510(k) clearance for MALE REMEEX SYSTEM, manufactured by Specialities Remeex International, S.L.. The device is a Class 2 Gastroenterology & Urology device with product code OTM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K062341 · Specialities Remeex International, S.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
84d
Days
Class 2
Risk

K062341 is an FDA 510(k) clearance for the MALE REMEEX SYSTEM. Classified as Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM), Class II - Special Controls.

Submitted by Specialities Remeex International, S.L. (Minneapolis, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Specialities Remeex International, S.L. devices

FDA 510(k) Submission Details - K062341

510(k) Number K062341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2006
Decision Date November 02, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTM Device Classification - Class 2, Special Controls

Product Code OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

All 9
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